Stylage M - Dermal tissue reconstructive material, microbe-derived

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
AA-Med Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
292900

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Public Summary

Summary for ARTG Entry:

292900

Australasian Medical & Scientific Ltd - Stylage M - Dermal tissue reconstructive material, microbe-derived

ARTG entry for

Medical Device Included Class III

Sponsor

Australasian Medical & Scientific Ltd

Postal Address

PO Box 5197,WEST CHATSWOOD, NSW, 1515

Australia

ARTG Start Date

17/08/2017

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Laboratoires VIVACY

252 Rue Douglas Engelbart Archamps

Technopole

, Archamps, 74160

France

Products

1. Stylage M - Dermal tissue reconstructive material, microbe-derived

Product Type

Single Device Product

Effective date

17/08/2017

GMDN

59131 Dermal tissue reconstructive material, microbe-derived

Functional description

Sterile, cross-linked hyaluronic acid gel with physiological pH and osmolarity. When injected, the device

generates volume by filling in the treatment area and is reabsorbed over time. The device is packed in a

1mL pre-filled syringe.

Intended purpose

Stylage® M is an injectable hyaluronic acid gel, intended to fill in facial skin depression (i.e. treatment of

nasolabial folds) by injection into the dermis, by a skilled legally qualified practitioner trained in techniques

for injecting implants.

Variant information

Nil variant (as 1 device) Not Applicable

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 24.11.2017 at 06:47:31 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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